Hepatitis B, Post-exposure; Prophylaxis

1.Hepatitis B, Postexposure; Prophylaxis household exposure in infants less than 12 months of age, acute hepatitis B infection in mother or primary caregiver: 0.5 mL IM as a single dose plus hepatitis B vaccine. 2.HepaGam B(R), Nabi-HB(R) (perinatal transmission prophylaxis in infants born to HBsAg-positive mothers) 0.5 mL IM within 12 hours of birth plus appropriate hepatitis B vaccine series [3][5]; for infant born to mothers not screened for HBsAg, if mother is found to be HBsAg-positive, give 0.5 mL IM as soon as possible and within 1 week after birth plus appropriate hepatitis B vaccine series. 3.HyperHEP B(R) (perinatal transmission prophylaxis in infants born to HBeAg- or HBsAg-positive mothers) 0.5 mL IM within 12 hours of birth plus appropriate hepatitis B vaccine series; if hepatitis B vaccine is delayed for as long as 3 months, then give hepatitis B immune globulin and repeat at 3 months; if hepatitis B vaccine is refused, then give hepatitis B immune globulin and repeat at 3 and 6 months.

Distribution Systemic: Vd: 15.3 ± 6.2 L Elimination Half Life Systemic: 24.8 ± 5.6 d

Anaphylactic or severe systematic reactions to parenteral human globulin. IgA deficiency; increased risk of anaphylactoid reaction.

C

There are no data on the excretion of hepatitis B immune globulin into human milk.

Common Dermatologic: Erythema at injection site (12% ), Injection site pain (4% ) Gastrointestinal: Nausea (2% to 4% ), Vomiting (2% ) Hematologic: Decreased white blood cell count (Mild) (2% ), Ecchymosis (Mild) (2% ) Hepatic: Alkaline phosphatase raised (Mild) (4% ), AST/SGOT level raised (Mild) (2% ) Musculoskeletal: Joint stiffness (Mild) (2% ), Myalgia (10% ) Neurologic: Headache (14% ) Renal: Serum creatinine raised (Mild) (2% ) Other: Malaise (6% )

Hepatitis B, Postexposure; Prophylaxis HepaGam B(R) (blood exposure to HBsAg-positive source) 0.06 mL/kg IM as a single dose as soon as possible and preferably within 7 days of exposure; give a second dose 1 month later to known non-responders to hepatitis B vaccine or in those who refuse vaccination. HepaGam B(R) (sexual exposure to HBsAg-positive source) 0.06 mL/kg IM as a single dose and initiate hepatitis B vaccine series within 14 days of sexual contact or if sexual contact will continue. HyperHep B(R), Nabi-HB(R) (unvaccinated persons with percutaneous or permucosal exposure to HBsAg-positive source) 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure if possible, and initiate hepatitis B vaccine series; OR if person refuses hepatitis B vaccine, 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure, and a second dose 1 month later. HyperHep B(R), Nabi-HB(R) (unvaccinated persons with percutaneous or permucosal exposure to known high-risk source) if source is found to be HBsAg-positive, 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure if possible, and initiate hepatitis B vaccine series; OR if person refuses hepatitis B vaccine, 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure, and a second dose 1 month later. HyperHep B(R), Nabi-HB(R) (vaccinated persons with percutaneous or permucosal exposure to HBsAg-positive source) if exposed person has an inadequate anti-hepatitis B antibody response, 0.06 mL/kg IM as a single dose and booster hepatitis B vaccine as soon as possible and within 24 hours of exposure if possible; OR if person refuses hepatitis B vaccine, 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure, and a second dose 1 month later. HyperHep B(R), Nabi-HB(R) (vaccinated persons with percutaneous or permucosal exposure to known high-risk source) if exposed person is vaccine non-responder and source is found to be HBsAg-positive, 0.06 mL/kg IM as a single dose and booster hepatitis B vaccine as soon as possible and within 24 hours of exposure if possible; OR if person refuses hepatitis B vaccine, 0.06 mL/kg IM as a single dose as soon as possible and within 24 hours of exposure, and a second dose 1 month later. HyperHep B(R), Nabi-HB(R) (sexual exposure) 0.06 mL/kg IM as a single dose within 14 days of the last sexual contact or if sexual contact with the infected person will continue; also begin the hepatitis B vaccine series at the same time the dose of hepatitis B immune globulin is given. HyperHep B(R), Nabi-HB(R) (contact with household member with acute hepatitis B virus infection and identifiable blood exposure such as sharing toothbrushes or razors) 0.06 mL/kg IM as a single dose within 14 days of exposure or if exposure to the blood of the infected person will continue; also begin the hepatitis B vaccine series at the same time the dose of hepatitis B immune globulin is given; all household contacts should receive hepatitis B vaccine if the source patient becomes a hepatitis B virus carrier.

Hepatitis B, Postexposure; Prophylaxis household exposure in infants less than 12 months of age, acute hepatitis B infection in mother or primary caregiver: 0.5 mL IM as a single dose plus hepatitis B vaccine. HepaGam B(R), Nabi-HB(R) (perinatal transmission prophylaxis in infants born to HBsAg-positive mothers) 0.5 mL IM within 12 hours of birth plus appropriate hepatitis B vaccine series ; for infant born to mothers not screened for HBsAg, if mother is found to be HBsAg-positive, give 0.5 mL IM as soon as possible and within 1 week after birth plus appropriate hepatitis B vaccine series. HyperHEP B(R) (perinatal transmission prophylaxis in infants born to HBeAg- or HBsAg-positive mothers) 0.5 mL IM within 12 hours of birth plus appropriate hepatitis B vaccine series; if hepatitis B vaccine is delayed for as long as 3 months, then give hepatitis B immune globulin and repeat at 3 months; if hepatitis B vaccine is refused, then give hepatitis B immune globulin and repeat at 3 and 6 months.

No adjustment recommended

No adjustment recommended

1.Do not shake vial to avoid foaming; do not use if turbid . 2.If dilution is preferred prior to IV administration, dilute with NS; do NOT use D5W. 3.HepaGam B(R) is for single use only; discard unused portions. 4.Store under refrigeration (2 to 8 degrees Celsius; 36 to 46 degrees Fahrenheit); do not freeze. Use Nabi-HB(TM) and HepaGam(TM) within 6 hours after the vial has been entered.